The Associate Principal Medical Writer will interact with other medical writers, document managers, document quality reviewers, and cross-functional teams (e.g., SMT, CDT, process improvement committees), in order to create/author/manage documentation required to support clinical trials and regulatory submissions. Successful candidate will participate in cross-functional teams and influences decision making. They may lead strategy discussions related to document development and make recommendations for process improvements within department and participates in discussions to implement change.

Principal Accountabilities

·       Independently prepares moderately complex clinical documents for one or more programs; coordinates preparation of clinical documents by other writers with minimal supervision

·       Represents department on clinical teams (e.g., SMT, CDT); leads document-related meetings; reviews statistical analysis plans and clinical data reports as needed

·       Mentors junior writers on departmental processes related to document preparation (e.g., planning document-related meetings, developing document timelines); reviews documents written by junior writers for content and format

·       Participates on departmental initiatives

·       Master’s required in a life science or health discipline. PhD preferred

·       4+ yrs. regulatory writing experience within a life science organization

·       Ability to interpret data within a specific therapeutic area (neuroscience ideal)

·       Solid understanding of standard clinical document types

·       Solid understanding of internal and external guidelines related to document preparation

·       Strong written and oral communication skills

·       Strong organizational and meeting skills

All your information will be kept confidential according to EEO guidelines.